Early Rehabilitation of Cancer Patients
1 other identifier
interventional
300
1 country
1
Brief Summary
A life threatening disease such as cancer may lead to post traumatic stress disorder, and even when reporting low levels of side-effects from cancer disease and treatment, 80% report high levels of stress symptoms. The purpose of the present randomised controlled trial is to examine the psychosocial effects of a stress management intervention based on cognitive behaviour therapy and with focus on increased physical activity in patients with various cancer diagnoses using a stepped-care approach. When using a stepped-care approach it is possible to study the level and intensity of stress management intervention required to achieve increased well-being. A cost-utility analysis will also be performed. 300 adult patients with a recent diagnosis of breast-, colorectal- prostate, testicular cancer or lymphoma and scheduled for adjuvant and/or curative oncologic treatment at Haukeland University Hospital, will be consecutively included in the prospective intervention study. The patients will be randomized to intervention or control. In step 1, all patients in the intervention group (I-a) will receive 2 counselling sessions. Patients who report clinically significant levels of stress, such as intrusive thoughts/avoidance behaviour (measured by Impact of Event Scale) and/or worry and depressions (measured by Hospital and Depression Scale) will be included in Step 2 (I-b) and include another 4-7 counselling sessions. There will also be a focus on motivating to increase physical activity level. Both the intervention (I) and control group (C) are allowed to take part in the common rehabilitation program with patient education and physical training. Data will be collected with self-reported standardized questionnaires. Objectively measures of physical activity level, sleep and daily energy expenditure are recorded with SenseWearâ„¢ Pro3 Armband. Measure point is at inclusion and than after 6 week, 4, 8, 12 and 24 month.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started May 2011
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 30, 2012
CompletedFirst Posted
Study publicly available on registry
April 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFebruary 29, 2024
October 1, 2015
4.3 years
January 30, 2012
February 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in psychosocial status
from baseline to 24 month
Secondary Outcomes (1)
Cost effectiveness of the stress-management intervention.
24 month
Study Arms (2)
Stressmanagement counselling
OTHERControl
NO INTERVENTIONInterventions
Individual stepped-care approach stressmanagement by specially trained counsellor
Eligibility Criteria
You may qualify if:
- Newly diagnosed with breast cancer,
- colorectal cancer,
- lymphoma,
- prostate cancer or testicle cancer and scheduled for adjuvant and/or curative treatment in the form of chemotherapy, radiation therapy and/or hormonal therapy at the Department of Oncology and Medical physics, Haukeland University Hospital, (Dept. of Oncology) Bergen,
- residence in Rogaland, Hordaland and Sogn and fjordane county council,
- initial treatment for cancer
You may not qualify if:
- An ongoing psychiatric condition,
- language deficiencies in Norwegian,
- surgery for prostate cancer (only applies for prostate cancer) patients),
- men with breast cancer,
- live in nursing homes,
- previous cancer,
- treated for cancer earlier,
- already implemented oncological treatment,
- not self-reliant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haukeland University Hospitallead
- University of Bergencollaborator
- Uppsala Universitycollaborator
- University of Agdercollaborator
Study Sites (1)
Department of Oncology and Medical Physics, Cancer center for Education and rehabilitation, Haukeland University Hospital
Bergen, 5021, Norway
Related Publications (1)
Arving C, Thormodsen I, Brekke G, Mella O, Berntsen S, Nordin K. Early rehabilitation of cancer patients - a randomized controlled intervention study. BMC Cancer. 2013 Jan 7;13:9. doi: 10.1186/1471-2407-13-9.
PMID: 23294513DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2012
First Posted
April 30, 2012
Study Start
May 1, 2011
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
February 29, 2024
Record last verified: 2015-10